Regulatory Affairs Specialist (NEW Position)

Формат работы

onsite

Тип работы

fulltime

Грейд

middle

Английский

Страна

Вакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:

TL;DR

Regulatory Affairs Specialist (NEW Position) (Pharmaceutical Regulatory Affairs): Preparing and submitting Korean NDA and variation applications for ophthalmology products, responding to MFDS requests, and monitoring Korean pharmaceutical regulations with an accent on regulatory submissions, change controls, and local compliance. Focus on managing K-NDA and variation registrations, creating Korean-language artworks, and providing regulatory guidance to cross-functional stakeholders.

Location: Seoul, South Korea; full-time onsite role

Company

hirify.global is a Japan-originated global life sciences company focused exclusively on ophthalmology, developing treatments and digital solutions for eye health.

What you will do

Prepare and submit Korean NDA applications for new products and variation applications for approved products to the Korean Ministry of Food and Drug Safety (MFDS).
Prepare timely responses and supporting documents for requests from Korean health authorities.
Evaluate change controls, regulatory requirements, and expected submission schedules.
Monitor Korean pharmaceutical regulations, guidelines, and health authority directions, sharing relevant updates with stakeholders.
Provide regulatory insights to cross-functional members and create Korean-language product artworks compliant with local regulations and internal standards.

Requirements

Bachelor’s degree in Pharmacy is highly preferred; a degree in Life Sciences or a related field is also considered.
More than 3 years of regulatory affairs experience at pharmaceutical companies in Korea.
Knowledge of Korean pharmaceutical legislation and regulations, preferably covering both chemical and biologic products.
Understanding of Korean registration procedures for NDA, variations, K-DMF, and other regulatory scopes.
Experience registering Korean NDAs and/or variations; experience with both NDA and BLA registrations is preferred.
Fluent Korean and English reading, writing, and speaking skills are required.

Nice to have

Experience at a foreign pharmaceutical company.
Experience leading a regulatory project from initiation to completion.

Culture & Benefits

Work within a global ophthalmology-focused life sciences organization with a 130-year heritage and operations in more than 60 countries.
Flexible ways of working and an inclusive physical and virtual workplace.
Opportunities to contribute to treatments, education, and digital solutions addressing vision-related social issues.
Equal opportunity employment and accommodation during the recruitment process.

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